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DITROPAN ELIXIR 2.5MG/5ML

Active substance(s): OXYBUTYNIN HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

2. Before you take Ditropan Elixir

Ditropan 2.5mg/5ml Elixir
Oxybutynin hydrochloride

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start taking this
medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ditropan Elixir is and what it is used for
2. Before you take Ditropan Elixir
3. How to take Ditropan Elixir
4. Possible side effects
5. How to store Ditropan Elixir
6. Further information



1. What Ditropan Elixir is, How Ditropan Elixir works
and What Ditropan Elixir is used for

What Ditropan Elixir is
Ditropan Elixir contains a medicine called oxybutynin hydrochloride.
This belongs to two groups of medicines called ‘anticholinergics’ and
‘antispasmodics’.
How Ditropan Elixir works
It works by relaxing the muscles of the bladder and stops sudden muscle
contractions (spasms). This helps control the release of water (urine).
What Ditropan Elixir is used for
Ditropan Elixir can be used in adults and children 5 years or older to
treat:
• Loss of control in passing water (urinary incontinence)
• Increased need or urgency to pass water (urine)
• Night time bedwetting, when other treatments have not worked

Do not take this medicine and tell your doctor if:
You are allergic (hypersensitive) to oxybutynin hydrochloride or
any of the other ingredients of Ditropan Elixir (listed in Section 6
below) Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
You have a rare muscle illness called ‘Myasthenia gravis’
You have glaucoma (increased pressure in the eye, sometimes
sudden and painful with blurred vision or loss of vision)
Your gut (stomach or intestine) is blocked, perforated or not
working properly
You have a severe form of a condition known as ‘ulcerative colitis’
You have a blockage that makes it difficult for you to pass water
(urine)
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Ditropan
Elixir.
Take special care with Ditropan Elixir
Check with your doctor or pharmacist before taking your
medicine if:
s You are 65 years of age or older
s The person taking the medicine is a child (use is not recommended
under 5 years of age)
s You have kidney or liver problems
s You have an illness affecting the nerves called ‘autonomic

neuropathy’
s You have an overactive thyroid gland (‘Hyperthyroidism’)
s You have heart disease or high blood pressure
s You have an irregular heart beat (palpitations) and/or increased or
rapid heart beat
s You have an enlarged prostate gland
s You have indigestion or heart burn caused by a ‘hiatus hernia’
(where part of your stomach pushes through the diaphragm)
s You have a raised body temperature or fever
s You will be taking this medicine in a hot climate
s Ditropan may reduce the amount of saliva resulting in tooth decay
or fungal infection of the mouth
Ditropan can cause glaucoma (increased pressure in the eye) please
contact your doctor immediately if you suffer any blurred vision, loss of
vision or have any pain in the eye.
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before taking Ditropan Elixir.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Ditropan Elixir
can affect the way some other medicines work. Also some medicines can
affect the way Ditropan Elixir works.
In particular, tell your doctor if you are taking
any of the following:
• Other anticholinergic or antimuscarinic
medicines - such as some medicines for
irritable bowel syndrome, asthma or incontinence, motion sickness or
movement disorders associated with Parkinson's disease
• Medicines used to make you feel sleepy (sedatives) or if you are
feeling sick (nausea) or have vertigo - such as prochlorperazine or
chlorpromazine
• Medicines used to treat certain mental illnesses - such as clozapine,
phenothiazines, haloperidol or benperidol (butyrophenones)
• Medicines for depression - such as amitriptyline, imipramine or
dosulepin (‘tricyclic antidepressants’)
• Amantadine - used in Parkinson’s disease or to treat and prevent
some virus infections
• L-dopa - used to treat Parkinson’s disease
• Digoxin - used to treat heart problems
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if:
• You are pregnant, might become pregnant or think you may be
pregnant
• You are breast-feeding or planning to breast-feed. This is because
small amounts may pass into mothers’ milk. Breast feeding while
using oxybutynin is therefore not recommended
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.
Driving and using machines
You may feel drowsy or have blurred vision while you are taking this
medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Ditropan
Elixir
This medicine contains:
• Sorbitol and sucrose: these are types of sugars. If you have
been told by your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to your doctor before
taking this medicine.
• Sodium methyl-p-hydroxybenzoate: this may cause an allergic
reaction (this might not happen straight away). Signs of an allergic
reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
P0728

TM

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Product:

Ditropan Elixir 2.5mg/5ml
Elixir Oxybutynin hydrochloride

Date:

Strength:

2.5mg/5ml

Proof Number:

New Item Code:

P0728

Page:

Previous Item Code:

P0599

New Pharmacode:

Design Icon:

Sanofi Aventis

Sugar-Free

NO

Cutter Ref:

-

Pack Size

150ml

Dimensions:

210 x 300mm (folded 150 x 30mm)

Number of 
colours used:

ONE

Reflex Blue

06.06.14
FOUR
1 of: 2

217
Barcode:

Keyline

Tick
applicable
box

3. How to take Ditropan Elixir
Always take Ditropan Elixir exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Do not give this medicine to children under
5 years old
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor

How much to take
Your doctor will decide the dose appropriate for you.
Adults
• The usual dose is 5mg (10ml) two or three times each day
• Your doctor may decide to increase to the maximum dose of
5mg (10ml) four times each day
Elderly
• The usual dose is 2.5mg (5ml) twice each day

• Your doctor may decide to increase this to 5mg (10ml) twice each
day
Children (over 5 years)
• The usual dose is 2.5mg (5ml) twice each day
• Your doctor may decide to increase this to 5mg (10ml) two or three
times each day
• If you are giving it to a child to prevent bedwetting, give the last
dose just before bedtime
If you take more Ditropan Elixir than you should
If you take more Ditropan Elixir than you should, tell a doctor or go to a
hospital casualty department straight away. Take the medicine pack with
you. This is so the doctor knows what you have taken.
Taking too much Ditropan Elixir can be very dangerous. You may
become very restless or excited, flushed or get dizzy or light-headed. Your
heart beat may become very fast, uneven or forceful. You may get
breathing problems or numbness or go into a coma.
If you forget to take Ditropan Elixir
If you forget a dose, take it as soon as you remember it. However, if it is
nearly time for the next dose, skip the missed dose. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Ditropan Elixir
Keep taking Ditropan Elixir until your doctor tells you to stop. Do not
stop taking Ditropan Elixir just because you feel better.

4. Possible side effects
Like all medicines, Ditropan Elixir can cause side effects, although not
everybody gets them. Children are at higher risk of the effects.

Stop taking Ditropan Elixir and see a doctor or go to a hospital
straight away if:
Frequency unknown
• You have an allergic reaction. The signs may include: a rash,

swallowing or breathing problems, swelling of your, lips, face, throat
or tongue
• You may feel reduced sweating, leading to overheating in hot

environments
Tell your doctor or pharmacist if any of the following side effects
get serious or lasts longer than a few days:
Very common (affects more than 1 in 10 people)
• Constipation
• Nausea
• Dry mouth
• Feeling sick, being sick
• Dry skin, rash or skin that is more sensitive to the sun
• Headache
• Somnolence (feeling drowsy or sleepy)
• Dizziness
• Blurring of vision
Common (affects 1 to 10 people in a 100 people)
• Dry eyes
• Diarrhoea
• Being sick (vomiting)
• Confusion
• Flushing especially in children
Uncommon (affects 1 to 10 people in a 1,000)
• Stomach pain
• Loss of appetite (anorexia)
• Difficulty in swallowing (dysphagia)
Frequency unknown
• Increased pressure in the eyes sometimes sudden and painful with
blurred vision or loss of vision (glaucoma)
• Indigestion or heartburn (acid reflux)
• Urinary tract infection
• Heat stroke
• Difficulty passing water (urine)
• Agitation
• Anxiety
• Becoming dependent on Ditropan
• Feeling excessive suspicious and distrustful of others
• Seeing or hearing things that are not there (hallucinations)
• Drowsiness
• Nightmares
• Fits (convulsions)
• Depression
• Increased heart beat (tachycardia)
• Irregular heart beat (arrhythmia)
• Dilation of pupil (mydriasis)
• Itchy, lumpy rash (urticaria)
• Absence of sweating (hypohidrosis)
• Skin that is more sensitive to the sun (photosensitivity)

TM

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Product:

Ditropan Elixir 2.5mg/5ml
Elixir Oxybutynin hydrochloride

Date:

Strength:

2.5mg/5ml

Proof Number:

New Item Code:

P0728

Page:

Previous Item Code:

P0599

New Pharmacode:

Design Icon:

Sanofi Aventis

Sugar-Free

NO

Cutter Ref:

-

Pack Size

150ml

Dimensions:

210 x 300mm (folded 150 x 30mm)

Number of 
colours used:

ONE

Reflex Blue

06.06.14
FOUR
2 of: 2

217
Barcode:

Keyline

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203
Level 3, Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Ditropan Elixir
Keep this medicine in a safe place where children cannot see or reach it
Do not use Ditropan Elixir after the expiry date which is stated on the
label, carton or bottle after EXP.
The expiry date refers to the last day of that month.
Store below 25°C. Keep the bottle in the outer carton in order to protect
from light.
Discard any medicine remaining 28 days after opening the bottle.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Further information
What Ditropan Elixir contains
• Each 5ml of elixir contains 2.5mg of the active substance, oxybutynin
hydrochloride.
• The other ingredients are citric acid monohydrate, sodium citrate,
sucrose, sorbitol, glycerol, sodium methyl-p-hydroxybenzoate and
purified water
What Ditropan Elixir looks like and contents of the pack
Ditropan Elixir is a clear and colourless elixir. It is supplied in bottles of
150ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford, Surrey, GU1 4YS
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Rosemont Pharmaceuticals Ltd, Leeds, LS11 9XE, UK
This leaflet does not contain all the information about your medicine. If
you have any questions or are not sure about anything, ask your doctor
or pharmacist.
This leaflet was last revised in 05/2014
© sanofi, 2001 - 2014
P0728
2

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applicable
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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